The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule (SPIRITDZSM1)

Guangzhou University of Traditional Chinese Medicine

Status and phase

Completed

Phase 4

Conditions

Stroke

Treatments

Drug: placebo

Drug: Dengzhan Shengmai capsule

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00548223

2006BAI04A02 (Other Grant/Funding Number)

Details and patient eligibility

About

In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143 subjects are included in 83 clinical research centers all over China. The subjects are randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke health education, management of blood pressure, blood lipid and blood glucose, etc. The treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the contrast group will take the placebo for twelve months. Then all of the subjects are visited on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.

Full description

Objective:To observe the secondary clinical effect of the Deng Zhan Sheng Mai capsule on ischemic stroke patients.

Methods:3143 subjects suffering from acute ischemic stroke are included in 83 clinical research centers all over China. The subjects are randomly divided into two groups:The treating group and the placebo group.Both groups accept the basic therapy and test drug.The basic therapy included antiplatelet aggregation,stroke health education,management of blood pressure,blood lipid and blood glucose,etc.The patients in Dengzhan Shengmaigroup take Deng Zhan Sheng Mai capsule and the placebo group take the placebo drug for twelve months.Then all of the subjects are visited on the 30th,90th,180th,360th day after inclusion. Primary endpoints(cerebral infarction,intracerebral hemorrhage,subarachnoid hemorrhage) and secondary endpoints(cardiovascular events,peripheral arterial disease),functional disability are observed at each follow up.

Enrollment

3,143 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

40-75 years old
Ischemic stroke diagnosed by CT/MRI scan
Patient presenting from 14 days to 6 months of first onset of ischemic stroke
Presence of at least one risk factor of stroke (such as hypertension, diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.) that can be interfered in
Informed consent

Exclusion criteria

Silent cerebral infarction
Cerebral infarction due to other causes except artery scleroses (i.e. cardiogenic embolism, hypercoagulable state, endangium stripping, vasculitis)
Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage mental disorder and noncooperation with physician
Females during pregnancy or lactation
Already attend other clinical trial